BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX EPIFUSE EPIDURAL CATHETER CONNECTOR

    MDR report key: 24999746 · Received April 27, 2026

    Report

    Report Number
    3012307300-2026-04204
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    CAZ
    UDI-DI
    10351688076083
    PMA / PMN Number
    K092657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. D4 - LOT #: PROVIDED LOT # 6091752 BUT COULD NOT BE LOCATED IN ORACLE H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER PLACEMENT THEY COULD NOT BE ABLE TO INJECT THE TEST DOSE VIA THE EPIDURAL CATHETER. THREE ATTEMPTS WITH HIGH PRESSURE WERE UNSUCCESSFUL (2ML AND 5ML SYRINGE). THE CHANGE OF THE CONNECTING DEVICE WASN¿T SUCCESSFUL EITHER. THE CATHETER WAS THEREFORE REMOVED, AND A NEW MEDLINE CSE KIT WAS USED MAKING SURE THAT THE CATHETER IS PATENT BEFORE PLACEMENT. THE CUSTOMER WAS UNABLE TO FULLY INSERT THE CATHETER INTO THE CATHETER CONNECTOR. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46744 PORTEX EPIFUSE EPIDURAL CATHETER CONNECTOR ANESTHESIA CONDUCTION KIT CAZ ICU MEDICAL, INC. 6091752 10351688076083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown